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Abstract

METHOD DEVELOPMENT AND VALIDATION OF EVEROLIMUS BY USING RP-HPLC

Devavath Renuka*, Nalla Kumar P. and Bhagavan Raju M.

ABSTRACT

Objective: To develop and validate the RP-HPLC method for estimation of Everolimus in bulk and pharmaceutical formulation. Materials and methods: Estimation of Everolimus were carried out by RP-HPLC using Mobile phase Buffer: Acetonitrile (40:60) and column std ODS (250×4.6mm, 5μ) as a stationary phase and peak was observed at 268nm which was selected as a wavelength for estimation. Results: Method was developed and this method was validated as per ICH guidelines for specificity, linearity, precision, accuracy, robustness studies. Conclusion: All the validated parameters were within the limits. The method was found to be suitable for the estimation of Everolimus in bulk and pharmaceutical formulation.

Keywords: HPLC Everolimus, Method development. ICH Guidelines.


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